STALIF MIDLINE

GUDID 00815101029337

Centinel Spine, Inc.

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00815101029337
• NIH Device Record Key: d10e7775-b837-4ca7-974f-2558ac80e84d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STALIF MIDLINE
• Version Model Number: STM6030R
• Company DUNS: 949024850
• Company Name: Centinel Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815101029337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141942

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-03-20

On-Brand Devices [STALIF MIDLINE]

• 00815101029344: STM6035R
• 00815101029337: STM6030R
• 00815101029320: STM6025R
• 00815101029313: STM6035
• 00815101029306: STM6030
• 00815101029290: STM6025